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CTRI Number  CTRI/2023/11/060292 [Registered on: 28/11/2023] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational 
Study Design  Other 
Public Title of Study   A study to evaluate anaesthetic managements in children undergoing radiotherapy  
Scientific Title of Study   AN OBSERVATIONAL STUDY OF ANAESTHETIC MANAGEMENTS IN CHILDREN UNDERGOING RADIOTHERAPY IN A TERTIARY CANCER CARE CENTRE: A PROSPECTIVE AUDIT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4272_Version 1.0 dated 12.05.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhavi Desai 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819253331  
Fax    
Email  maddes08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi Desai 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9819253331  
Fax    
Email  maddes08@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhurima Sen 
Designation  PG Student 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9836599479  
Fax    
Email  madhurimasen95@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical Care and Pain, Tata Mmeorial Hospital, Parel 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, Tata Mmeorial Hospital, Parel 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhavi Desai  Tata Memorial Centre  Department of Anesthesia Critical care and Pain Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA 
9819253331

maddes08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMH Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Children of age 1 day-15 years
2. Children undergoing radiotherapy (brachytherapy or teletherapy)
3. Children referred for anesthesia
 
 
ExclusionCriteria 
Details  1. Children >15 years of age
2. Children not referred for anesthesia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) The method of management required i.e. anesthesia/ reward therapy/ distraction method/ none
2) The pre-procedural fasting practices
3) The pre-procedural medications administered
4) Airway events & management during procedure
5) Hemodynamic events & management during procedure
6) Recovery after the procedure & management required
 
Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure 
 
Secondary Outcome  
Outcome  TimePoints 
1) Course of IV access  Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

As a tertiary cancer care centre, we at Tata Memorial Hospital witness a large number of pediatric oncology cases, both solid tumor and hematologic. Needless to say, cancer contributes significantly to the mortality and morbidity of pediatric patients. Most solid tumor cases require external beam radiotherapy (EBRT) at some point in their treatment course, whether with a curative or palliative intent (reduces pain, preserves organ function and maintains hollow organ lumen patency).

Anesthesia or procedural sedation may be required for the procedure depending on a variety of factors including the patient’s age, cognitive function, emotional maturity, pain, musculoskeletal deformities, treatment requirements (like the prone position), claustrophobia. Children are posted for 10-28 sessions of teletherapy or 8-10 sessions of brachytherapy. Usually, children less than 6-7 years and older children with claustrophobia require procedural sedation for radiotherapy, whereas, older children cooperate by distraction or reward.

This study will focus on the day-care anesthesia practices in pediatric RT (IV sedation/inhalational anesthesia), the outcomes, patterns of anesthesia (choice of Induction agent, route of administration, premedication, duration of procedure), recovery time, issues after patient’s discharge from the hospital, longevity of a peripheral IV access line, airway considerations (difficult airway, desaturation, laryngo-/bronchospasm, excessive secretions) in Tata Memorial Hospital, Mumbai over a period of 1 year, with interim analysis at 6 months or till 600 procedures and their outcomes are recorded, whichever is earlier.

 
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